Product code FTC
- Device name
- Light, Ultraviolet, Dermatological
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4630
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254234 | Phototherapy System (DUV-COMBO) | Choyang Medics Co., Ltd. | 2026-05-01 |
| K253871 | Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC | 2026-03-04 |
| K250425 | Ultraviolet Phototherapy Device | APK Technology Co., Ltd. | 2025-04-07 |
| K244022 | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) | Boston Aesthetics, Inc. | 2025-03-13 |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-02-06 |
| K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) | Shanghai Sigma High-Tech Co., Ltd. | 2024-12-19 |
| K233811 | DT Controlled Phototherapy Equipment | Daavlin Distributing Co. | 2023-12-13 |
| K223882 | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) | Shenzhen Honpal Optoelectronic Technology Co., Ltd. | 2023-03-27 |
| K230382 | 3 Series NeoLux | Daavlin Distributing Co. | 2023-03-24 |
| K230076 | Enhanced AURORA™ Medical Diode System, and related accessories | Psoria-Shield, Inc. | 2023-03-08 |
| K220840 | 1 Series Phototherapy Equipment | Daavlin Distributing Co. | 2022-04-22 |
| K210004 | i8 Tanning Booth | Ultrasun International B.V. | 2021-12-10 |
| K212510 | 7 Series Phototherapy Device | Daavlin Distributing Co. | 2021-11-04 |
| K210881 | M Series Phototherapy Equipment | Daavlin Distributing Co. | 2021-06-22 |
| K202827 | 308nm Excimer UV-light Skin Therapy System | Shenzhen Gsd Tech Co., Ltd. | 2020-12-15 |
| K200971 | 308nm Excimer System | Xuzhou Kernel Medical Equipment Co., Ltd. | 2020-12-15 |
| K192411 | Psoria-Shield AURORA | Psoria-Shield | 2020-07-02 |
| K192642 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | 2020-05-13 |
| K191571 | UV Radiation Treatment System | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2020-02-06 |
| K191086 | Exciplex | Clarteis | 2019-12-11 |
| K181805 | UV Phototherapy | Xuzhou Kernel Medical Equipment Co., Ltd. | 2019-01-11 |
| K182215 | ClearLink Controlled Phototherapy Equipment | Daavlin Distributing Company | 2018-10-29 |
| K172273 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | 2018-07-30 |
| K173436 | Luma Light System | Luma Therapeutics | 2018-01-30 |
| K171702 | Exciplex308nm | Clarteis | 2017-10-13 |
| K170489 | Skylit Phototherapy System | Skylit Medical | 2017-05-23 |
| K153749 | 3 Series Phototherapy Unit | Daavlin Distributing Company | 2016-06-30 |
| K151795 | ML24000 UVA-1 Phototherapy Cabinet | Daavlin Distributing Co. | 2015-09-10 |
| K150752 | GME ExSys 308 | Gme (German Medical Engineering) GmbH | 2015-07-31 |
| K150912 | Houva-NET Control System | National Biological Corporation | 2015-07-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06946725599990 | APK | APK Technology Co.,Ltd. | 2025-09-22 |
| B219E780MUVBNB0 | Solarc/SolRx E-Series | Solarc Systems Inc | 2025-04-01 |
| B219E790MUVBNB0 | Solarc/SolRx E-Series | Solarc Systems Inc | 2025-04-01 |
| 06928798600377 | Kernel | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-03-11 |
| 06928798600384 | Kernel | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-03-11 |
| 06928798600391 | Kernel | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-03-11 |
| 06928798600421 | Kernel | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-03-11 |
| 06928798600438 | Kernel | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-03-11 |
| 06928798600445 | Kernel | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-03-11 |
| 06928798600452 | Kernel | Xuzhou Kernel Medical Equipment Co., Ltd. | 2025-03-11 |
| 00810182930930 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-13 |
| 00810182930183 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930176 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930169 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930152 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930145 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930138 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930121 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930114 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930107 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930091 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930084 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930077 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930060 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930053 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930046 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930039 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930022 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930015 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |
| 00810182930008 | DAAVLIN | DAAVLIN DISTRIBUTING CO., THE | 2024-12-12 |